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Treatment of Sleep Apnea Syndrome with nCPAP Versus Oral Appliance. - Article


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Sleep Apnea

Apnea; Apnea, Sleep


Clinical Trial: Treatment of Sleep Apnea Syndrome with nCPAP Versus Oral Appliance.

This study is currently recruiting patients.
Verified by University Hospital Angers February 2005

Sponsored by: University Hospital Angers
Information provided by: University Hospital Angers
ClinicalTrials.gov Identifier: NCT00152672

Purpose

This prospective randomized cross over study aims to compare nCPAP with mandibular advancement device for the treatment of sleep apnea syndrome.The effectiveness of nCPAP and oral appliance on apnea-hypopnea index, daytime sleepiness and quality of life will be compared in 60 patients.
Condition Intervention
Sleep Apnea Syndrome
 Device: nCPAP vs oral appliance

MedlinePlus related topics:  Sleep Apnea

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Official Title: Treatment of Sleep Apnea Syndrome with nCPAP Versus Oral Appliance: a Muticentre Prospective Randomized Crossover Trial.

Further Study Details: 

Expected Total Enrollment:  60

Study start: June 2005

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Male
Criteria

Inclusion Criteria:

18 to 70 years old BMI < 35 kg/m2 Apnea-hypopnea index between 10 and 60 events/h Complaint of snoring and sleepiness Dental status adequate for treatment with oral appliance informed consent

Exclusion Criteria:

psychiatric disease professional driver other cause of sleepiness

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00152672

Frédéric Gagnadoux, MD      33(0)241353695    frgagnadoux@chu-angers.fr

France
      CHU, Angers,  49033,  France; Recruiting
Frédéric Gagnadoux, MD  33(0)241353695    frgagnadoux@chu-angers.fr 
Frédéric Gagnadoux, MD,  Principal Investigator

Study chairs or principal investigators

Frédéric Gagnadoux,  Principal Investigator,  UH Angers   

More Information

Study ID Numbers:  PHRC 04-10
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152672
Health Authority: France: French General Health Administration
ClinicalTrials.gov processed this record on 2005-09-13


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May 13, 2008



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